JAMA Pediatr

Montelukast and neuropsychiatric risk in children: New study findings cast doubt

January 22, 2025

Montelukast doesn’t appear to increase the risk of neuropsychiatric adverse events in children and adolescents. The findings support the continued use of montelukast for managing asthma and allergic rhinitis in pediatric patients, alleviating concerns raised by previous reports and FDA's 2020 boxed warning.

Study details: This nationwide register-based cohort study, conducted by researchers at NIH's Eunice Kennedy Shriver National Institute of Child Health and Human Development, analyzed data from 74,291 children ages 6 to 17 years in Sweden. The study compared 26,462 montelukast users with 47,829 long-acting β-agonist (LABA) users, tracking neuropsychiatric adverse events using diagnosis codes and prescription records from January 2007 to November 2021.

Results: No significant association was found between montelukast use and neuropsychiatric adverse events. The incidence rates of neuropsychiatric events were 2.39 per 100 patient-years among montelukast users and 2.41 per 100 patient-years among LABA users. Hazard ratios for specific neuropsychiatric adverse events were also similar between groups:

• Anxiety: 0.79 (95% confidence interval [CI], 0.54-1.14)
• Depression: 1.16 (95% CI, 0.70-1.95)
• Sleep-related disorders: 0.93 (95% CI, 0.76-1.13)
• Suicide and suicidal actions: 1.31 (95% CI, 0.64-2.69)
• Disrupted control of activity, attention, and behavior: 1.27 (95% CI, 0.84-1.90)
• Confusion and psychotic-like symptoms: 0.51 (95% CI, 0.05-5.53)

Source:

Wintzell V, et al. (2025, January 21). JAMA Pediatr. Montelukast Use and the Risk of Neuropsychiatric Adverse Events in Children. https://pubmed.ncbi.nlm.nih.gov/39836401/